US FDA Drug Label (Product information) updates related to safety – November 2020

US FDA Drug Label (Product information) updates related to safety - November 2020

US FDA Drug Label (Product information) updates related to safety – November 2020

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US FDA Drug Label (Product information) updates related to safety – November 2020: The U.S. Food and Drug Administration (FDA) has updated the drug labels. 

Do you want to know what are the Drug labels updated?

The following one or more sections have been updated in each drug label update.

  • Boxed Warning
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Drug Interactions
  • Use in Special Populations
  • Patient Counseling Information
  • Patient Information
  • Medication Guide

US FDA Drug Label (Product information) updates related to safety – November 2020

Active Ingredient Application Type FDA Database Updated
Abacavir Sulfate NDA 11/25/2020
Abacavir Sulfate NDA 11/25/2020
Acetaminophen NDA 11/19/2020
Alvimopan NDA 11/24/2020
Amoxicillin; Clarithromycin; Omeprazole NDA 12/01/2020
Amoxicillin; Omeprazole Magnesium; Rifabutin NDA 12/01/2020
Apalutamide NDA 11/24/2020
Aspirin; Omeprazole NDA 12/01/2020
Atezolizumab BLA 11/18/2020
Atorvastatin Calcium NDA 11/18/2020
Atropine NDA 11/24/2020
Avelumab BLA 11/16/2020
Azelaic Acid NDA 12/01/2020
Baloxavir Marboxil NDA 11/25/2020
Cefazolin Sodium NDA 11/25/2020
Ceftaroline Fosamil NDA 12/01/2020
Cemiplimab-Rwlc BLA 11/16/2020
Cetuximab BLA 11/16/2020
Ciprofloxacin; Dexamethasone NDA 11/09/2020
Crofelemer NDA 11/19/2020
Dexlansoprazole NDA 11/30/2020
Dexrazoxane Hydrochloride NDA 11/04/2020
Docetaxel NDA 11/25/2020
Dorzolamide Hydrochloride; Timolol Maleate NDA 11/25/2020
Dronedarone Hydrochloride NDA 11/23/2020
Durvalumab BLA 11/24/2020
Eculizumab BLA 11/23/2020
Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor NDA 11/23/2020
Enasidenib Mesylate NDA 11/25/2020
Esomeprazole Magnesium NDA 11/30/2020
Esomeprazole Magnesium NDA 11/30/2020
Esomeprazole Magnesium NDA 11/30/2020
Esomeprazole Magnesium; Naproxen NDA 11/30/2020
Esomeprazole Sodium NDA 11/30/2020
Esomeprazole Strontium NDA 12/01/2020
Estrogens, Conjugated Synthetic A NDA 12/02/2020
Estrogens, Conjugated Synthetic B NDA 12/02/2020
Formoterol Fumarate; Glycopyrrolate NDA 11/09/2020
Haloperidol Decanoate NDA 11/23/2020
Haloperidol Lactate NDA 11/23/2020
Ioversol NDA 11/23/2020
Ioversol NDA 11/23/2020
Ioversol NDA 11/23/2020
Ioversol NDA 11/23/2020
Ipilimumab BLA 11/18/2020
Lacosamide NDA 11/23/2020
Lacosamide NDA 11/23/2020
Lacosamide NDA 11/23/2020
Lansoprazole NDA 11/30/2020
Lansoprazole NDA 11/30/2020
Liraglutide Recombinant NDA 11/25/2020
Lubiprostone NDA 12/09/2020
Midostaurin NDA 11/25/2020
Nivolumab BLA 11/18/2020
Ocrelizumab BLA 11/10/2020
Olaparib NDA 11/04/2020
Omalizumab BLA 12/02/2020
Omeprazole Magnesium NDA 11/30/2020
Omeprazole; Sodium Bicarbonate NDA 12/11/2020
Omeprazole; Sodium Bicarbonate NDA 12/11/2020
Pantoprazole Sodium NDA 12/01/2020
Pantoprazole Sodium NDA 11/30/2020
Pantoprazole Sodium NDA 11/30/2020
Pantoprazole Sodium NDA 12/01/2020
Pegvaliase-Pqpz BLA 11/23/2020
Pembrolizumab BLA 11/16/2020
Perflutren NDA 11/23/2020
Pimavanserin Tartrate NDA 11/25/2020
Pimavanserin Tartrate NDA 11/25/2020
Prucalopride Succinate NDA 11/16/2020
Rabeprazole Sodium NDA 11/30/2020
Rabeprazole Sodium NDA 12/01/2020
Rifaximin NDA 11/13/2020
Romiplostim BLA 11/25/2020
Sulfamethoxazole; Trimethoprim NDA 11/23/2020
Sulfamethoxazole; Trimethoprim NDA 11/23/2020
Tafenoquine Succinate NDA 11/18/2020
Temozolomide NDA 11/25/2020
Temozolomide NDA 11/25/2020
Teriflunomide NDA 11/09/2020
Teriparatide Recombinant Human NDA 11/23/2020
Testosterone NDA 12/02/2020
Ticagrelor NDA 11/09/2020
Tigecycline NDA 11/19/2020
Topiramate NDA 11/23/2020
Venetoclax NDA 11/24/2020
Vortioxetine Hydrobromide NDA 11/19/2020

Source: U.S. Food and Drug Administration


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